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2018-11-01
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Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device
Rules and Regulations
D09002ee1c172984f
D09002ee1c172989d
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the insulin therapy adjustment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
83 FR 54873
https://www.govinfo.gov/app/details/FR-2018-11-01/2018-23912
2018-23912
fr01no18-5
4164-01-P
Docket No. FDA-2018-N-3648
https://www.govinfo.gov/app/details/FR-2018-11-01/2018-23912
https://www.govinfo.gov/content/pkg/FR-2018-11-01/html/2018-23912.htm
https://www.govinfo.gov/content/pkg/FR-2018-11-01/pdf/2018-23912.pdf
Medical Devices
3 p.
54873
54875
83 FR 54873
Code of Federal Regulations
Title 21 Part 862
21 CFR Part 862
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device; Federal Register Vol. 83, Issue
RULE
2018-23912
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-11-01
Docket No. FDA-2018-N-3648
4164-01-P
2018-23912
Final order.
The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the insulin therapy adjustment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective November 1, 2018. The classification was applicable on June 12, 2018.
Dina Jerebitski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301- 796-2411, Dina.Jerebitski@fda.hhs.gov.
Medical Devices
Medical Devices:
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device
,
Dina.Jerebitski@fda.hhs.gov
Federal Register
Vol. 83, no. 212
Office of the Federal Register, National Archives and Records Administration
2018-11-01
continuing
daily
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240 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-11-01
P0b002ee19d93ce75
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr01no18
https://www.govinfo.gov/app/details/FR-2018-11-01
https://www.govinfo.gov/content/pkg/FR-2018-11-01/pdf/FR-2018-11-01.pdf
https://www.govinfo.gov/content/pkg/FR-2018-11-01/xml/FR-2018-11-01.xml
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DGPO
2018-11-01
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FR-2018-11-01
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FR-2018-11-01
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